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Generex Biotechnology Corporation (GNBT) Provides Update on Company Initiatives Including the AE37 Breast Cancer Vaccine Program


11/13/2012 11:13:49 AM

WORCESTER, Mass. and TORONTO, Nov. 13, 2012 /PRNewswire/ -- Generex Biotechnology Corporation (OTCBB:GNBT) today provided the following update on company initiatives.

Antigen Express, Inc. (www.antigenexpress.com), a wholly-owned subsidiary of Generex, is in late Phase II clinical development of a novel immunotherapeutic for breast cancer (AE37) that demonstrates promising trends in preventing relapse. The interim results of the large, controlled, randomized, and single blinded trial were the subject of an end of Phase II study report written for submission to the FDA with input from the Antigen Express AE37 Breast Cancer Vaccine Scientific Advisory Board (SAB) of Internationally-recognized experts in the field of breast cancer.

Based on this report, in response to the written request for the end of Phase II meeting with the FDA, the Company was given the option of proceeding expeditiously with the submission of a protocol for the Phase III study.  As the Phase III trial design has been established with the advice of the SAB, the Company is proceeding with the development of a full Phase III protocol, electing to do this under the auspices of a special protocol assessment (SPA). The SPA process was developed by the FDA as a means to ensure that the trial design and endpoints are acceptable to the agency and thereby expedite the approval process once the endpoints are met.

In particular, the specific population planned for the Phase III trial are those patients with low levels of expression of the HER2 oncoprotein who are not eligible for treatment with the drug Herceptin.  Representing a significant, unmet need in the management of breast cancer, this low-HER2 population is twice the size of the high-HER2 population (who are candidates for treatment with Herceptin).  Subject to the availability of funding, Antigen Express expects to initiate this Phase III trial in 2013.

Generex will require additional funds for day-to-day operations and to continue the on-going AE37 clinical and regulatory work.  In addition to other potential sources, Generex is attempting to re-finance its current real estate holdings.

About Generex Biotechnology Corporation

Generex is engaged in the research, development, and commercialization of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company's proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company's proprietary RapidMist device. Antigen Express, Inc. is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutic vaccines for the treatment of malignant, infectious, allergic, and autoimmune diseases. Antigen Express has pioneered the use of specific CD4+ T-helper stimulation technologies in immunotherapy. One focuses on modification of peptides with Ii-Key to increase potency while a second relies on inhibition of expression of the Ii protein. Antigen Express scientists, and others, have shown clearly that suppression of expression of the Ii protein in cancer cells allows for potent stimulation of T-helper cells and prevents the further growth of cancer cells. For more information, visit the Generex website at www.generex.com or the Antigen Express website at www.antigenexpress.com.

Cautionary Note Regarding Forward-Looking Statements

This release and oral statements made from time to time by Generex representatives in respect of the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plan," "believes," "will," "achieve," "anticipate," "would," "should," "subject to" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Generex cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials. Because of this, statements regarding the expected timing of clinical trials or ultimate regulatory approval cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials or when it will obtain ultimate regulatory approval by a particular regulatory agency. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

SOURCE Generex Biotechnology Corporation


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